# K050579: Mega Power Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Megadyne Medical Products, Inc.
- Decided: Mar 24, 2005 after 17 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944602 (1995). 1 ancestor in all.
16 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 2.

## Most influential descendants
- K053510: IR Wireless Foot Switch (2006), 12 descendants of its own
- K083161: Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100) (2009), 9 descendants of its own
- K100638: Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214 (2010), 8 descendants of its own
- K152777: Bovie Disposable Bipolar Ablator (2016), 3 descendants of its own
- K193145: Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch (2020), 2 descendants of its own

## Recalls of this device
- May 15, 2018 · Class II · Z-2792-2018: If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.

## Indications for use
General-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures.

Source page: https://510kreport.com/device/K050579
Methodology: https://510kreport.com/methodology